Kornimate/medical-research-clean huggingface dataset:
avelumab with laser interstitial therapy for recurrent glioblastoma

Conditions: Glioblastoma; GBM

Summary: the purpose of the study is to characterize the safety and tolerability of avelumab in combination with laser interstitial thermal therapy (litt) for blood barrier disruption in patients with recurrent glioblastoma.

this is an open label, non-randomized phase i study of intravenous avelumab every 2 weeks to be administered after real-time mri-guided litt therapy for patients with a first recurrence of a glioblastoma. the primary objective of the study is to characterize the tolerability and safety profile of avelumab in combination with mri guided litt administered to patients diagnosed with recurrent gbm. part a, the initial cohort of patients will be treated with intravenous avelumab alone. part b, patients will receive avelumab in combination with mri-guided litt to characterize the tolerability and safety of the combined treatment.

Eligibility criteria:
inclusion criteria: * patients must have histologically proven gbm from the initial resection. * patients must have a life expectancy \> 16 weeks. patients must have a karnofsky performance status of ≥ 60 or ecog 0 - 2 * patient's requirement for dexamethasone should be ≤ 4mg daily or a stable dose at enrollment. * patients must have adequate bone marrow, hepatic and renal function and hemoglobin and the test musts be performed within 14 days prior to study day 1. * highly effective contraception for both male and female subjects if the risk of conception exists. exclusion criteria: * known history of autoimmune disorder except diabetes mellitus type 1, vitiligo or hypothyroidism only requiring hormone replacement * patients who have received any other therapeutic investigational agent within 30 days of enrollment with the exception of the personalized mta vaccine (nct03223103) that can be continued throughout the study. * patients who have received any other therapeutic investigational agent within 30 days of enrollment or prior * prior placement of intracavitary bcnu-impregnated wafers (gliadel). * prior treatment with checkpoint inhibitors, ctl-4 antibody or other immunotherapy agents * presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment. * prior organ transplantation, including allogeneic stem cell transplantation * significant acute or chronic infections including, among others: hiv, aids, hbv * pregnancy or lactation contact site for full inclusion/exclusion list.

Keywords: gbm litt laser interstitial thermal therapy bavencio immunotherapy
efficacy of black seed oil in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .


Eligibility criteria:
inclusion criteria: 1. age: adult patients with more than or equal 18 years old. 2. previous diagnosis of diabetes mellitus type 2 according to american diabetes association criteria (ada). 3. approval to participate and give informed consent. exclusion criteria: 1. unstable coronary artery disease, cardiac arrhythmia or congestive heart failure. 2. uncontrolled hypertension or recent stroke. 3. chronic kidney disease or chronic liver disease. 4. intake of black seed oil during the previous two months or any other antioxidant.

Keywords: type 2 diabetes mellitus black seed oil endothelial dysfunction
safety and efficacy of aeb071 and everolimus in patients with cd79-mutant or abc subtype diffuse large b-cell lymphoma

Conditions: CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma

Summary: study of the safety and efficacy of aeb071 and everolimus in patients with cd79-mutant or abc subtype diffuse large b-cell lymphoma. the trial did not progress into phase ii due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the phase ib part of the study. there were no serious safety concerns associated with this combination.

this is a phase ib dose escalation and phase ii study in patients with dlbcl harboring mutations in cd79a/b or of the abc subtype. pre-screening for mutations in cd79a/b or the abc subtype will be required, as it is anticipated that both patient groups may receive clinical benefit from the combination of aeb071 and everolimus.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age. * diffuse dlbcl with activating mutations in cd79 (a or b subunits) or abc-subtype dlbcl (cd79 wildtype or cd79 mutant). dlbcl that arose from transformed indolent lymphoma is allowed. * prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as r-chop or r-epoch. there is no limit to number of prior therapies allowed. * may be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites. * who performance status of ≤ 2. * a representative ffpe tumor sample must be available for molecular testing along with a corresponding pathology report. an archival tumor sample may be submitted. however, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead. exclusion criteria: * treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome p450 3a4/5 (cyp3a4/5), or cyp3a4/5 substrates with a qt prolongation risk that cannot be discontinued at least 7 half-lives (or if the half-life is unknown,14 days) prior to study drug treatment. * impaired cardiac function or clinically significant cardiac diseases. * impairment of gi function or gi disease that could interfere with the absorption of aeb071 or everolimus. * severe systemic infections, current or within the two weeks prior to initiation of aeb071. * kown history of hiv. * poorly controlled diabetes as defined by a fasting serum glucose \> 2.0 x uln. * evidence of current cns involvement. * significant symptomatic deterioration of lung function.

Keywords: diffuse large b-cell lymphoma, dbcl, aeb071, everolimus
mental health services for toddlers in foster care

Conditions: Behavior Problems

Summary: toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. critical issues for toddlers straddle the challenges of infancy and preschool years. in particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. this project will assess the effectiveness of an intervention that targets these issues. attachment and biobehavioral catch-up for toddlers in foster care (abc-t) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. this intervention's effectiveness will be assessed in a randomized clinical trial.

this study assesses the efficacy of a 10-session intervention for young children in the foster care system. children are randomly assigned to the experimental condition (abc-t) or to a treatment control (def). in the attachment and biobehavioral catch-up for toddlers (abc-t) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. in the developmental education for families (def) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. outcomes include attachment (assessed in the preschool strange situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.

Eligibility criteria:
inclusion criteria: * 2 -3 years of age, in foster care exclusion criteria: * not in foster care
online support for outpatient peripheral arterial disease self-management

Conditions: Peripheral Artery Disease

Summary: this study looks to examine whether an online patient tool to monitor factors affecting patients peripheral artery disease can lead to improvements in patients' disease and slow its progression.

the objective of this project is to implement a program involving a new online patient-centred approach to assist in peripheral arterial disease (pad) self-management in home and work environments, in collaboration with patient circles of care (patients, care-givers, physicians, and allied healthcare professionals). this program involves online modules tailored to the needs of specific patients and diseases, oriented to education, training, monitoring, and continuing support for lifestyle changes (smoking cessation, exercise, healthy diets, weight loss, etc.) and psycho-social needs such as social isolation and loneliness. the investigators have tested an online desk-top version for over 30 out-patients with pad at st. michael's hospital in toronto. the investigators propose to test its ability for improved outcomes and healthcare quality of life through a multi-centre randomized controlled trial for pad and a frequently co-occurring chronic illness, high blood pressure.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * diagnosed with peripheral artery disease (abi\<0.9) exclusion criteria: * unable to communicate in english * unwilling to participate * patients with dementia or other cognitive impairment
a study to investigate drug interaction between d326, d337, and d013 in healthy male subjects

Conditions: Dyslipidemias; Hypertension

Summary: a study to investigate drug interaction between d326, d337, and d013 in healthy male subjects

an open-label, randomized, multiple-dose crossover study to investigate drug interaction between d326, d337, and d013 in healthy male subjects

Eligibility criteria:
inclusion criteria: 1. healthy volunteers aged between ≥ 20 and ≤ 45 years old 2. weight ≥ 50kg, with calculated body mass index(bmi) of ≥ 18 and ≤ 29.9kg/m² 3. subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm 4. subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study exclusion criteria: 1. history or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder 2. with symptoms indicating acute illness within 28 days prior to the first investigational product administration 3. any medical history that may affect drug absorption, distribution, metabolism and excretion 4. genetic problems such as galactose intolerance, lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 5. any clinically significant active chronic disease

Keywords: dyslipidemia hypertension ckd-386 drug-drug interaction
health-related quality of life in children and adolescents with clubfoot

Conditions: Clubfoot; Children; HRQOL (Health Related Quality Of Life)

Summary: this prospective cohort study aims to evaluate the health-related quality of life (hrqol) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the ponseti method. the study will assess hrqol using the pediatric quality of life inventory (pedsql 4.0) and clinical outcomes using the pbs clubfoot score (pbs). participants will be followed for 2 and 5 years to evaluate changes in hrqol and clinical function. the primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.


Eligibility criteria:
inclusion criteria: * children aged 2 to 15 years diagnosed with congenital clubfoot. * undergoing treatment or follow-up at drammen hospital. * both unilateral and bilateral cases included. * written informed consent from parents or legal guardians. exclusion criteria: * concurrent severe medical or psychological conditions affecting outcomes. * lack of written informed consent. * incomplete or missing data for pedsql or pbs assessments.

Keywords: hrqol pedsql children clubfoot ponseti
clinical prediction model and external validation of chronic postsurgical pain in elders

Conditions: Chronic Postsurgical Pain

Summary: this study will collect perioperative pain-related data of elderly patients in multi-centers. analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning models of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning. based on the database, the investigators intend to explore: * perioperative risk assessment methods and early warning models for elderly patients; * practical, safe, and effective risk prevention and control system through subsequent studies.

this study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning model of chronic postsurgical pain in elderly patients, so as to improve the ability of assessing the risks of chronic postsurgical pain in elderly patients and providing an early warning.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic postsurgical pain (cpsp) cpsp was made based on the guidelines of the international society for pain (cpsp: icd-11) as follows: chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. the pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain. * geriatric surgical patients ≥65 years old exclusion criteria: * patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.

Keywords: elderly chronic postsurgical pain prediction risk factors validation
continuous and wireless vital sign monitoring in patients at home after acute medical admission

Conditions: Vital Sign Monitoring; Clinical Deterioration; Disease Progression; Disease Attributes

Summary: the current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization

the healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. this increases the need for earlier discharge and for treatment shifted to the patients' own home. furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities. this study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge. data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion. exclusion criteria: * allergy to plaster, plastic, or silicone. * a pacemaker or implantable cardioverter defibrillator (icd) device. * if the patient was deemed not able to open the front door when visited by the investigator. * inability to give informed consent.
ain shams university experience: clinical determinants of hospitalized covid-19 patients

Conditions: Coronavirus Disease (COVID-19)

Summary: covid-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. so, it is important to investigate the egyptian clinical characteristics and different factors that determine the patient's 'outcome

investigators will convey the ain shams university experience as the first university in egypt to designate one of its hospitals (ain shams university obour hospital) for management of confirmed covid19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. it is a retrospective observational cohort study at ain shams university obour hospital. all adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome coronavirus (sars-cov-2)will be included. clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome coronavirus (sars-cov-2). * standard of care arm of the ongoing clinical trials will be included in our study. exclusion criteria: * mild cases who don't need hospitalization
registry of endovascular treatment for vertebrobasilar dissecting aneurysms in china

Conditions: Dissecting Aneurysm of Cerebral Artery

Summary: the incidence of vertebrobasilar dissecting aneurysms (vbdas) is about 1/100,000\~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. in recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. the natural prognosis of vbdas is complex and varied, with uncertainty: (1) it may have a benign course, and the imaging follow-up may show that the diseased vessels are repaired and improved or remain stable for a long period of time; (2) it may present with ischemic stroke caused by hemodynamic alteration or thromboembolism, which may result in severe neurological impairment; (3) it may occur as a result of rupture of aneurysms leading to subarachnoid hemorrhage, endangering the patient's life; (4) progressive enlargement of vbdas causing occupying effects, which may be manifested as headache in mild cases, or hemiplegia of limbs and choking on drinking water in severe cases. up to now, there is a lack of objective and uniform diagnostic and therapeutic guidelines for the natural regression of vbdas and the benefits of surgery, and the treatment is mostly empirical, which makes it difficult to accurately determine the clinical prognosis of vbdas and formulate appropriate treatment strategies. therefore, against the above background, we designed the present study. this study was a multicenter, prospective, registry study. we enrolled patients with unruptured vbdas who met the inclusion and exclusion criteria, and a multi-disciplinary team formulated the treatment modalities for the patients, which were categorized into the conservative observation group, the stent-assisted coiling group, and the flow diverter group. the aim of our study was to investigate the effects of different treatment modalities on the prognosis of patients with vbdas, as well as to stratify the risk factors of the patients, to explore the individualized treatment modalities of the patients, and to improve the diagnosis and treatment of this clinically refractory cerebrovascular disease.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years old; 2. patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm". exclusion criteria: 1. patients did not undergo a cranial mri; 2. missing critical clinical baseline; 3. missing pre-treatment imaging; 4. receiving microsurgery; 5. the combination of other serious diseases during diagnosis will significantly affect the follow-up of patients; 6. ct/mri shows intracranial hemorrhage or subarachnoid hemorrhage (swi microbleeds are ignored).

Keywords: vertebrobasilar dissecting aneurysms endovascular treatment prognosis hemorrhagic stroke